Extended Self-Help for Smoking Cessation Project Summary Tobacco smoking is the leading preventable cause of cancer mortality. Although both pharmacotherapy and behavioral counseling have independent and additive effects toward aiding smoking cessation, counseling is rarely chosen by smokers. In contrast, minimal self-help interventions, such as smoking cessation pamphlets or booklets have much wider potential reach, but their efficacy has been very disappointing, with incremental abstinence rates averaging only 1 percent. Any significant improvement in the efficacy of self-help would have potentially large public health impact with respect to smoking and smoking-related illness and mortality. Previous efforts by this research team have led to the development of a series of 8 self-help booklets designed to reduce postcessation relapse to smoking. Two clinical trials have demonstrated that these "Forever Free" booklets significantly reduce smoking relapse through two years of follow-up among recent quitters, and that the intervention is extremely cost-effective. Moreover, recent secondary analyses suggest that the booklets not only reduced relapse among recent quitters, but they also improved cessation rates among a subset of smokers who requested the booklets for cessation rather than relapse-prevention purposes. The incremental abstinence rates were much larger than typically found from self-help. These analyses also indicated that-in contrast to relapse-prevention-the booklets were efficacious only when they their delivery to smokers was distributed over 12 months. We have proposed a general two-process "Transitional Approach to Drug Abstinence" model to account for these differences. The model emphasizes the role of continued contact to maintain individuals'motivation for smoking cessation. Conclusions from the secondary analyses are limited because the studies were not powered to detect outcome differences for smoking cessation, and the sample may not have been representative of smokers in general. In addition, the significant outcome differences were not maintained after the 12 months of booklet distribution ended. The aims of the proposed study are: (1) To test the efficacy of Forever Free booklets for smoking cessation, via a sufficiently powered randomized clinical trial;(2) To test the incremental efficacy of extending and increasing the frequency of contact;(3) To compare the cost-effectiveness of the interventions;and (4) to test a subset of predictions of our model. Smokers will be randomized to one of three intervention arms: (1) Usual Care, a single NCI smoking cessation booklet;(2) Standard Repeated Mailings, the 8 Forever Free booklets over 12 months;and (3) Intensive Repeated Mailings, which adds another 6 months of mailings and additional supportive contacts between the booklet mailings. Follow-up will occur at 6-month intervals through 30 months post-enrollment. The primary hypotheses are that Standard Repeated Mailings will produce significantly (e5 percent) greater abstinence rates compared to Usual Care, and that the Intensive condition will improve sustained abstinence beyond that. PUBLIC HEALTH RELEVANCE: It has been estimated that 21 percent of all US deaths can be attributed to tobacco smoking. Effective low-cost interventions that are easy to disseminate have high potential for reducing the public health burden of smoking. The proposed study will test a self-help intervention consisting of a series of mailed booklets that has shown evidence of significant efficacy in preliminary studies.